NCT00274534已完成3 期
A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.
研究概览
简要总结
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.
时间窗: up to day 90
次要结局
- Occurrence of adverse events(up to day 90)
- Pulse rate and sitting blood pressure in conjunction with spirometry(up to day 90)
- Maximum increase in alveolar-arterial oxygen gradient from baseline(up to day 90)
- Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter(up to day 90)
- Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter(up to day 90)
- Maximum decline in PaO2 from baseline(up to day 90)
- Rescue medication use(up to day 90)
- COPD symptom score(up to day 90)
研究者
研究点 (2)
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